CSV Validation Specialist Position

5 days ago

Dublin, Dublin City, Ireland beBeeValidation Full time €70,000 - €90,000
Pharmaceutical Validation Engineer

CERTIFIED CREGG is currently seeking a Pharmaceutical Validation Engineer with expertise in automation platforms and lifecycle documentation within the pharmaceutical sector on a long-term contract. This is a site-based role, and a Valid Irish work permit is essential.

Key Responsibilities:
  • Act as the Subject Matter Expert (SME) in CSV as and when needed.
  • Participate and lead CSV activities linked to Automation projects.
  • Support the preparation of GxP Computerised System Lifecycle documents, including validation plans, requirement specifications, risk assessments, qualification protocols, requirements traceability matrices, and validation reports.
  • Design, generate, and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing.
  • Evaluate computer systems and their associated documentation for compliance with site-specific policies and regulations, good manufacturing practices, and industry regulations.
  • Lead risk assessment before test execution, including ERES and system functional risk assessments.
  • Review vendor validation documents, such as validation protocols and validation summary reports.
  • Participate in deviation investigation, analysis, and change assessment.
Required Qualifications:
  • Second-level qualifications in Electrical, Electronic, Systems Engineering, or Computer Science.
  • 5+ years' experience working in control systems validation in the Life Sciences/Pharma sector.
  • Excellent communication and technical writing skills.
  • Experience with PLC/SCADA and OSIsoft PI Data Historian Validation.
  • Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, and 21 CFR Part 11.
  • A Valid Irish work permit.
Work Environment:
  • Mid-senior level.
  • Full-time.

This is a straight CSV validation engineering role focused on lifecycle documentation, testing, and compliance within a pharmaceutical automation environment.

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